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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Cranioplasty, Preformed, Alterable
510(k) Number K131775
Device Name UNIVERSAL NEURO 3 SYSTEM
Applicant
Stryker
750 TRADE CENTRE WAY
STE 200
PORTAGE,  MI  49002
Applicant Contact Manish Patel
Correspondent
Stryker
750 TRADE CENTRE WAY
STE 200
PORTAGE,  MI  49002
Correspondent Contact Manish Patel
Regulation Number882.5320
Classification Product Code
GWO  
Subsequent Product Codes
GXR   HBW  
Date Received06/17/2013
Decision Date 10/17/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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